Encouraged by a breakthrough designation at the FDA and its latest batch of upbeat data from a Phase II study of its anti-CD19 antibody MOR208, MorphoSys says it’s blazing a straight path to regulators in search of an accelerated approval.
MorphoSys execs spent a good deal of time talking to analysts yesterday about their reasons for shooting at a quick OK. The German biotech highlighted updated data demonstrating that of the 68 evaluable patients in their study for diffuse large B cell lymphoma — a popular disease target in oncology — they tracked a 49% overall response rate and a 31% complete response rate.
They also have a preliminary progression free survival rate of 50.5% at 12 months.
This is a single arm study of the MorphoSys antibody combined with lenalidomide for 81 DLBCL patients not eligible for high-dose chemo or autologous stem cell transplantation. And it says a lot about why biotechs are barreling into cancer with high expectations of breaking new ground earlier than ever.
Malte Peters, the chief development officer at MorphoSys, spelled it out for analysts:
Specifically 29 out of 33 patients which have responded, that amount to 88% are ongoing, 20 of whom have an ongoing complete response. The mean time to respond was short with 1.8 months and the mean time to experience a complete response was 3.6 months….
At this time, we are hoping to be able to submit data from the current L-MIND trial to the FDA as a basis for regulatory approval. Our goal is to achieve an accelerated approval based primarily on the L-MIND study. Apart from L-MIND, we are currently investigating MOR208 in the same patient population in our Phase III B-MIND trial. This is a head-to-head study investigating the efficacy of MOR208 plus bendamustine versus rituximab plus bendamustine. Rituximab plus bendamustine is one of the most commonly used regimens in the relapse refractory DLBCL setting.
The FDA already has this drug down in the special BTD path based on an earlier snapshot of data from the same study. That gives MorphoSys a reasonable hope that it can move fast toward a filing while lining up the bigger Phase III as a confirmatory study.
At this point, the accelerated approval pathway has been blazed by a mob of developers who needed to show that they were doing a reasonable percentage of late-stage patients some good. The FDA has responded with alacrity, and regulators in the US are only picking up even more speed under the direction of FDA commissioner Scott Gottlieb. MorphoSys – allied with a group of A-list partners on other drugs – has good reason to believe that they can take the same short cut.
Noted CEO Simon Moroney:
“We are very encouraged by our most recent clinical data from the ongoing L-MIND trial, which support our plan to develop MOR208 in combination with lenalidomide as a chemo-free treatment option for this patient population.”
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